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Long-term of Remote Ischemic Preconditioning in Patients With Mild Hypertension

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Antihypertensive drugs
remote ischemic preconditioning(RIPC)
lifestyle intervention
Sponsored by
Henan Institute of Cardiovascular Epidemiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed patients with mild hypertension (SBP: 140~159mmHg; DBP: 90~99mmHg)

Exclusion Criteria:

  • Cannot tolerate RIPC
  • Non-essential hypertension
  • patients who have uncontrolled severe arrhythmia, diabetes, electrolyte disturbance
  • patients who have severe organic diseases such acute myocardial infarction, cardiac insufficiency, abnormal renal function, etc.

Sites / Locations

  • Fuwai central China Cardiovascular hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Experimental A: Drug group+lifestyle intervention

Experimental B: RIPC group+lifestyle intervention

Experimental c: lifestyle intervention

Arm Description

Experimental group A used only one antihypertensive drug (ACEI / ARB, beta blocker, calcium channel blocker, diuretic, etc.) plus lifestyle intervention to control blood pressure.

The experimental group B received ripc treatment of upper limbs every day plus lifestyle intervention until the end of the follow-up. The treatment time was 40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles.

The control group take lifestyle intervention to control blood pressure, such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.

Outcomes

Primary Outcome Measures

Mean systolic blood pressure
24-hour Mean systolic blood pressure measured by Ambulatory blood pressure monitoring
Mean diastolic blood pressure
24-hour Mean diastolic blood pressure measured by Ambulatory blood pressure monitoring

Secondary Outcome Measures

Concentration of Renalase
blood renalase concentration
Concentration of catecholamine
Blood catecholamine concentration
Concentration of adenosine
blood adenosine concentration
Concentration of bradykinin
blood bradykinin concentration
Concentration of renin
blood renin concentration

Full Information

First Posted
February 10, 2021
Last Updated
August 3, 2022
Sponsor
Henan Institute of Cardiovascular Epidemiology
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1. Study Identification

Unique Protocol Identification Number
NCT04753840
Brief Title
Long-term of Remote Ischemic Preconditioning in Patients With Mild Hypertension
Official Title
Long-term of Remote Ischemic Preconditioning in Patients With Mild Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2021 (Actual)
Primary Completion Date
February 20, 2023 (Anticipated)
Study Completion Date
February 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Institute of Cardiovascular Epidemiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
According to the latest survey data of China hypertension annual meeting, there are about 300 million patients with hypertension in China, with 10 million new cases of hypertension each year, and there is an obvious trend of younger people. In particular, young and middle-aged people are in a state of mild hypertension for a long time, which causes great pressure on health and medical treatment. At present, the main clinical measures for mild hypertension are to change their eating habits, quit smoking and alcohol, exercise and other lifestyle changes, as well as drug control. For most patients with mild hypertension, drug control is not the best choice. It has been reported that remote ischemic preconditioning (RIPC) may play an effective role in reducing blood pressure .The purpose of this study was to investigate the extent of long-term application of RIPC to reduce blood pressure in patients with mild hypertension.
Detailed Description
A total of 200 patients with mild hypertension were enrolled in this study, using the method of open label and parallel grouping; 100 cases in the experimental group and 100 cases in the control group, The experimental group was divided into life intervention + drug group and life intervention + ripc group, with 50 patients in each group. The results of 24-hour ambulatory blood pressure monitoring (ABPM) of the three groups were observed before and 3 months after use, including HR, pulse pressure, 24-hour systolic blood pressure, 24-hour diastolic blood pressure, daytime systolic blood pressure, daytime diastolic blood pressure, nighttime systolic blood pressure and nighttime diastolic blood pressure. The changes of renalase, catecholamine, renin, angiotensin - Ⅱ, aldosterone, RhoA kinase, no, adenosine and bradykinin were observed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental A: Drug group+lifestyle intervention
Arm Type
Experimental
Arm Description
Experimental group A used only one antihypertensive drug (ACEI / ARB, beta blocker, calcium channel blocker, diuretic, etc.) plus lifestyle intervention to control blood pressure.
Arm Title
Experimental B: RIPC group+lifestyle intervention
Arm Type
Experimental
Arm Description
The experimental group B received ripc treatment of upper limbs every day plus lifestyle intervention until the end of the follow-up. The treatment time was 40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles.
Arm Title
Experimental c: lifestyle intervention
Arm Type
Other
Arm Description
The control group take lifestyle intervention to control blood pressure, such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.
Intervention Type
Other
Intervention Name(s)
Antihypertensive drugs
Intervention Description
One of ACEI / ARB, beta blocker, calcium channel blocker, diuretic
Intervention Type
Other
Intervention Name(s)
remote ischemic preconditioning(RIPC)
Intervention Description
40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention
Intervention Description
Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.
Primary Outcome Measure Information:
Title
Mean systolic blood pressure
Description
24-hour Mean systolic blood pressure measured by Ambulatory blood pressure monitoring
Time Frame
3 months
Title
Mean diastolic blood pressure
Description
24-hour Mean diastolic blood pressure measured by Ambulatory blood pressure monitoring
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Concentration of Renalase
Description
blood renalase concentration
Time Frame
3 months
Title
Concentration of catecholamine
Description
Blood catecholamine concentration
Time Frame
3 months
Title
Concentration of adenosine
Description
blood adenosine concentration
Time Frame
3 months
Title
Concentration of bradykinin
Description
blood bradykinin concentration
Time Frame
3 months
Title
Concentration of renin
Description
blood renin concentration
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed patients with mild hypertension (SBP: 140~159mmHg; DBP: 90~99mmHg) Exclusion Criteria: Cannot tolerate RIPC Non-essential hypertension patients who have uncontrolled severe arrhythmia, diabetes, electrolyte disturbance patients who have severe organic diseases such acute myocardial infarction, cardiac insufficiency, abnormal renal function, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
En Li
Phone
13525070525
Email
1799077212@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muwei Li, MD
Organizational Affiliation
Fuwai Central China Cardiovascular Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fuwai central China Cardiovascular hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muwei Li, MD
Phone
+8613838083966
Email
lmw0207@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD can be obtained from the researcher upon reasonable request
Citations:
PubMed Identifier
24627443
Citation
Jones H, Hopkins N, Bailey TG, Green DJ, Cable NT, Thijssen DH. Seven-day remote ischemic preconditioning improves local and systemic endothelial function and microcirculation in healthy humans. Am J Hypertens. 2014 Jul;27(7):918-25. doi: 10.1093/ajh/hpu004. Epub 2014 Mar 13.
Results Reference
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PubMed Identifier
21945497
Citation
Moro L, Pedone C, Mondi A, Nunziata E, Antonelli Incalzi R. Effect of local and remote ischemic preconditioning on endothelial function in young people and healthy or hypertensive elderly people. Atherosclerosis. 2011 Dec;219(2):750-2. doi: 10.1016/j.atherosclerosis.2011.08.046. Epub 2011 Sep 7.
Results Reference
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Long-term of Remote Ischemic Preconditioning in Patients With Mild Hypertension

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